Job Description

We are seeking a candidate with Director Level  experience in Document Management and Control.

Do you have at least 5 years  experience in Change Management in FDA-regulated, GxP-related industry?

Do you possess a  thorough knowledge of ICH guidelines and FDA cGMPs and guidelines? If yes, please connect with us today!

 

MUST HAVE:

  • BA/BS in the Life Sciences.

  • Minimum 7-10 years’ experience in Document Management and Control.

  • Minimum 3-5 years’ experience in Change Management in FDA-regulated, GxP-related Industry.

  • Comprehensive knowledge of document control principles, data integrity principles, and good documentation practices.

  • Working knowledge of electronic change management systems or e-QMS.

  • Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines.

  • MS degree in Life Sciences.

  • Knowledge of European and Japanese Health Authority requirements

SHIFT TIMINGS:

Monday-Friday, Day Shift--8AM-5PM

This is a hybrid (2 days on-site) position in the Allendale, NJ location.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.

More Details
Employment Type: Full Time
Location: Allendale , New Jersey , United States
Experience Required: Director/ Vice-President
Date Published: 20 Sep 2022
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